HealthIT Now asks HHS to rein in ONC
The Office of the National Coordinator for Health IT (ONC) has been responsible for guiding and overseeing much of the nation’s transition toward ubiquitous health IT, but a coalition of health IT groups is asking HHS Secretary Tom Price whether the office has recently exceeded its authority.
Particularly, in a letter to Secretary Price, HealthIT Now, a coalition of healthcare payers, providers and IT vendors, calls for HHS to reevaluate the agency’s role in EHR certification. “ONC’s proposal to directly review products if there are patient safety concerns encroaches on the statutorily required regulatory authority of other federal agencies, specifically the Food & Drug Administration,” the organization wrote. “Subjecting vendors to duplicate regulatory oversight is overly burdensome and should be addressed. We are also concerned this action is not supported by underlying statutory language in the HITECH Act.”
Moreover, the group said, ONC has adopted a “we’ll know it when we see it” approach when it comes reviewing products for non-conformities. “This lack of clarity could lead to vendors hesitating to volunteer products for ONC certification,” they cautioned.
In short, the group urged the administration “to better align the Certification Program with the needs of providers and patients under future CMS programs, such as the Quality Payment Program. It is worrisome that vendors are spending an increasing amount of time on conforming to certification requirements and in turn have less time to focus on the needs of their customers in meeting the needs of their patients.”
The ONC has “overstepped original authorities provided under the HITECH Act,” Robert Horne, executive director of Health IT Now, a coalition of healthcare payers, providers and IT vendors, wrote in a letter (PDF) addressed to HHS Secretary Tom Price. Horne raised specific concerns about the ONC’s approach to certifying EHRs for safety, arguing that approach opens vendors up to “duplicate regulatory oversight” from both the ONC and the Food and Drug Administration.
“It is worrisome that vendors are spending an increasing amount of time on conforming to certification requirements and in turn have less time to focus on the needs of their customers in meeting the needs of their patients,” Horne wrote, urging HHS to “clarify the role of ONC in the marketplace.”